Outcome of Different Complementary Feeding Methods in First Year of Life of Infants

NCT07467876 | Completed DMC

• 1 other identifier: SMBBIT
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aimed to compare adherence to two complementary feeding methods-Baby-Led Introduction to SolidS (BLISS) and Parent-Led Weaning (PLW)-in infants aged 6-12 months. A total of 130 infants aged 6-9 months were randomized to BLISS (n=65) or PLW (n=65) groups. Adherence was defined as self-feeding for BLISS and spoon-fed consistency for PLW. Follow-up continued until 12 months of age. The study found significantly higher adherence in the BLISS group compared to the PLW group (78.5% vs 52.3%, p=0.002).

Conditions

Complementary Feeding; Infant

Keywords

Adherence; Complementary Feeding; Infant; Weaning

Outcome Measures

Primary Outcomes (1)

• Adherence to Assigned Complementary Feeding Method

  Adherence was defined as the infant following the assigned complementary feeding approach: self-feeding of solid foods in the BLISS group and spoon-fed age-appropriate food consistency in the PLW group.

  From 6 months to 12 months of age

Study Arms (2)

(BLISS)

EXPERIMENTAL

Infants assigned to this group followed the Parent-Led Weaning (PLW) method, receiving spoon-fed complementary foods of appropriate consistency from 6 to 12 months of age.

Behavioral: Baby-Led Introduction to SolidS (BLISS)

(PLW)

ACTIVE COMPARATOR

A complementary feeding approach encouraging infant self-feeding with appropriately sized solid foods under caregiver supervision.

Behavioral: Parent-Led Weaning (PLW)

Interventions

Baby-Led Introduction to SolidS (BLISS) BEHAVIORAL

Caregivers were instructed to offer age-appropriate solid foods that infants could grasp and self-feed, following BLISS principles, with emphasis on safe textures, iron-rich foods, and close supervision during feeding.

Also known as: Baby-Led Weaning Modified Approach

(BLISS)

Parent-Led Weaning (PLW) BEHAVIORAL

Caregivers fed infants complementary foods using spoon-feeding techniques, progressing food texture and consistency according to age-appropriate feeding recommendations.

(PLW)

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 6-9 months at the time of enrollment
• Infants eligible for initiation of complementary feeding
• Parents or caregivers willing to follow the assigned feeding method
• Written informed consent obtained from the parent or legal guardian

You may not qualify if:

• Infants with congenital malformations affecting feeding
• Infants with neurological impairments
• Infants with known food allergies or dietary restrictions
• Infants with chronic illnesses affecting growth or feeding

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU), Larkana, Pakistan

Larkana, Sindh, Pakistan

Location

Study Officials

• Dr. Iqra hanif, MBBS

  Shaheed Mohtarma Benazir Bhutto Medical University (SMBBMU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: March 12, 2026
• Study Start: February 26, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 30, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)